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New York, NY – October 2, 2018 – Personalized treatment for advanced breast cancer is a massive global medical need. According to latest figures from the Centers for Disease Control, in the United States alone more than 41,000 women die from breast cancer each year. Hope is on the horizon, however, as innovative biomedical companies apply their research and technologies to bring personalized immunotherapies to market for this unmet medical need. Among these companies is BriaCell Therapeutics Corp. (OTC:BCTXF) (TSX-V:BCT), an immune-oncology-focused biotech company developing the first off-the-shelf personalized immunotherapy for advanced breast cancer. The company’s technology is based on a targeted immunotherapy regime that has seen encouraging results in clinical trials. Other biotechs in the personalized cancer immunotherapy space include Gilead Sciences, Inc. (NASDAQ:GILD), the parent company of Kite Pharma; Cellectis S.A. (NASDAQ:CLLS); Neon Therapeutics, Inc. (NASDAQ:NTGN); and Loxo Oncology, Inc. (NASDAQ:LOXO).
Personalized Immunotherapy for Advanced Breast Cancer: Rationale
The global market for breast cancer treatment reached an estimated $12 billion in 2017 and is on pace to reach approximately $19 billion by 2025. Within this market, precision medicine shows considerable promise. Personalized immunotherapy, an example of precision medicine in which a treatment is tailored to the individual patient, broadly aims to stimulate a patient’s own immune system to combat cancer. This personalized approach allows a physician to tailor the treatment to each individual patient, thereby potentially achieving higher effectiveness and fewer side effects.
Focused on revolutionizing advanced breast cancer treatment aligned with this approach, BriaCell’s (OTCQB:BCTXF) (TSX.V:BCT) off-the-shelf personalized immunotherapy treatment can be quickly prepared for each individual patient and is designed to safely kill the tumor cells while saving time, high cost and manufacturing complexities associated with making personalized immunotherapies.
The need for this caliber of technology is significant in the field of oncology, considering that one in eight women will develop invasive breast cancer over the course of their lifetime. Aside from skin cancer, breast cancer is the most commonly diagnosed cancer among women in the United States, and breast cancer death rates are higher than those for any other cancer except lung cancer. Advanced breast cancer, also called metastatic or stage IV breast cancer, is the most advanced and deadly form of the disease, causing the majority of breast cancer-related deaths.
Predictable Anti-Tumor Response in Phase IIa Clinical Studies in Advanced Breast Cancer
BriaCell’s novel technology is being developed based on the recent positive proof-of-concept clinical findings of phase IIa studies of the company’s lead product candidate, Bria-IMT™, in heavily pretreated advanced breast cancer patients.
Bria-IMT is derived from a specific breast cancer cell line and is genetically engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system. BriaCell believes that Bria-IMT helps the body to recognize and kill tumor cells by activating both T cells that directly attack tumor cells, and B cells that produce anti-tumor antibodies.
The phase IIa study (listed in ClinicalTrials.gov as NCT03066947) showed potent anti-tumor activity of Bria-IMT in certain patients who shared certain HLA types with Bria-IMT. (HLA = Human Leukocyte Antigen typing is used to match patients and donors in transplants.) HLA biomarkers, found on most cells, are recognized by the immune system to determine self versus foreign cells. Importantly, preliminary phase IIa efficacy data in these patients, with the same HLA type as those on Bria-IMT, were similar or superior to those of other approved breast cancer drugs when at a similar clinical-stage of development.
Click here to view a slide presentation of the results.
Leading the advancement of Bria-IMT and BriaCell’s pipeline is the company’s president and CEO, Dr. Bill Williams, who has been personally involved in the development of 10 drugs in the market.
Based on the recent findings related to the mechanism of action of Bria-IMT and the potential to produce intensified anti-tumor activity when used in combination with certain drugs, BriaCell is now focusing on the combination study of Bria-IMT with pembrolizumab (Keytruda®, manufactured by Merck & Co., Inc.) or ipilimumab (Yervoy®, manufactured by Bristol-Myers Squibb Company). The combination study is listed in ClinicalTrials.gov as NCT03328026.
It is important to note that immune checkpoint inhibitors such as pembrolizumab (anti-PD-1) and ipilimumab (anti-CTLA-4) have come to the forefront in the fight against cancer with substantial benefits for some patients. The significance of immune checkpoints has been recognized by the Nobel committee by awarding Drs. Honjo (PD-1) and Allison (CTLA-4) with the 2018 Nobel Prize in Physiology or Medicine. This is highly encouraging for BriaCell because the company is using these check point inhibitors in combination with Bria-IMT in its ongoing Phase IIa studies in advanced breast cancer patients.
“We believe that combination studies with immune checkpoint inhibitors should create even more potent anti-cancer immune responses, leading to our strategy of combination studies of Bria-IMT with Keytruda or Yervoy,” Williams stated in the press release announcing the results. “In our view, the combination of Bria-IMT with Keytruda or Yervoy has the potential to provide a new therapeutic option and substantial clinical benefit in heavily pre-treated advanced breast cancer patients where there remains a significant unmet need.”
Preliminary Proof-of-Concept Clinical Trials
The first clinical trial used the original unmodified breast cancer cell line, with GM-CSF and low dose cyclophosphamide to boost the immune response. In the trial, 14 patients were treated. Among positive results, no severe drug-related side effects were reported, and the treatment produced a post-treatment median survival rate about twice what was expected.
The second clinical trial used Bria-IMT (i.e., the original cell line modified to produce GMCSF) with cyclophosphamide and interferon-alpha in four advanced-stage cancer patients. The treatment was tolerated well with few side effects. The median overall survival was much longer than expected. The study also had one patient who responded extremely well to the treatment with an approximately 90 percent tumor reduction in the breast cancer.
After the treatment stopped (as required by the study), the patient’s breast cancer returned and had spread to the patient’s brain, lungs and other sites. Importantly, the patient was treated again with Bria-IMT, and the tumors were reduced at multiple sites, even in the brain. This patient matched Bria-IMT for certain genes called HLA genes, which are used to match patients to tissues in tissue transplantation, such as for kidney transplants.
Recent Clinical Findings (Phase I/IIa Study: 2017-2018)
As earlier noted, BriaCell achieved proof-of-concept in its phase IIa study of Bria-IMT with positive safety and excellent, predictable efficacy in patients with HLA matches with Bria-IMT. Importantly, initial safety data appeared superior to that of the other advanced or approved drugs for breast cancer when they were at a similar clinical stage of development. Most importantly, initial efficacy data was similar or superior to those of other advanced or approved drugs for breast cancer when they were at a similar clinical stage of development.
BriaCell has developed a companion diagnostic test, BriaDX™, that would allow a physician to prepare a personalized premade treatment for each patient based on the presence of certain biomarkers (HLA type). Testing is simple and performed on the patient’s saliva. This diagnostic test will be used in future clinical trials to accelerate the clinical development success for Bria-IMT and Bria-OTS™.
Based on BriaCell’s observation of superior tumor shrinking responses in the patients who shared certain biomarkers (i.e., HLA types) with Bria-IMT, BriaCell is developing Bria-OTS for advanced breast cancer. Bria-OTS includes a set of cell lines, each being similar to Bria-IMT, which are being engineered to express various premanufactured HLA types. With only 15 different HLA types, Bria-OTS cell line combinations are expected to cover more than 90 percent of the United States’ population. Bria-OTS is expected to enter the clinics in 2019.
As noted above, BriaDX is used to determine the HLA types of patients. Based on the results, one or two Bria-OTS premade cell lines will be selected to be administered to the patient. Thus, Bria-OTS is expected to provide the patient with fast, inexpensive, safe and effective personalized cancer immunotherapy treatment that can be readily ordered because it is premade.
This appears to be great news for patients and therapists who previously had few or no treatment options. The technology may be applicable to other cancers as well.
Other Biotechs on the Move
Gilead Sciences (NASDAQ:GILD) is the parent company of Kite Pharma, Inc., which develops immunotherapies. Kite Pharma’s therapies involve collecting and using the patient’s own immune cells to treat the cancer. The company’s focus is on developing engineered cell therapies that express either a chimeric antigen receptor (CAR) or a T cell receptor (TCR), depending on the type of cancer. With its dual platform approach, Kite Pharma’s technology is designed to address both hematological and solid tumor cancers. However, with this approach, each dose must be manufactured for each patient, which can be time consuming and costly, and may include a complex manufacturing system.
Cellectis S.A. (NASDAQ:CLLS) develops off-the-shelf immunotherapies using next-generation CAR T cells. Lead technology, TALEN®, is being developed to enable gene editing to precisely edit or change the genetic code within a person’s DNA. As with Kite Pharma’s approach, Cellectis’ manufacturing of treatment based on the patient’s own T cells could also be a costly and time consuming approach.
Neon Therapeutics’ (NASDAQ:NTGN) work on personalized immuno-oncology therapies lead the company to develop treatments across both T cell therapies and vaccines using neoantigen biology. Neon Therapeutics is developing multiple clinical strategies to target neoantigens, which are foreign substances encoded by tumor-specific mutated genes. This technology requires extensive genetic analysis of the patient’s tumor, another often time-consuming method saddled with potentially high cost.
Loxo Oncology (NASDAQ:LOXO) is focused on developing treatments for cancers caused by a single inappropriate DNA change, or an “oncogenic driver.” These drivers are responsible for both the initiation and the maintenance of a cancer. Loxo Oncology designs highly selective medicines that target these drivers as the underlying cause of a cancer. These therapies are targeted to the cancer of an individual patient, but do not work through the immune system and may be unlikely to eliminate all cancer cells from the body.
Personalized Cancer Immunotherapy: The Future of Treatment for Advanced Breast Cancer
Personalized, off-the-shelf treatments have the potential to revolutionize the way advanced breast cancer is treated. In a recent interview, Williams voiced the company’s commitment to bringing its personalized immunotherapy treatments to the patients with the disease.
“We remain confident in our technology’s potential to deliver clinical benefit to patients with advanced breast cancer, and are working hard to make Bria-OTS, BriaCell’s novel off-the-shelf personalized immunotherapy, available to advanced breast cancer patients as soon as possible,” he stated.
For more information about BriaCell Therapeutics, please visit BriaCell Therapeutics Corp. (OTCQB:BCTXF) (TSX.V:BCT).
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